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Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

NCT03078075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2021-05-03

Study results available
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Summary

This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.

Conditions

  • Methamphetamine Use Disorder

Interventions

DRUG

Naltrexone: Vivitrol®

Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks

DRUG

Placebo (PLB) Injectable

Placebo: 4 intramuscular injections administered every 3 weeks

DRUG

Bupropion: Wellbutrin XL®

Bupropion: 450 mg oral dose daily

DRUG

Placebo (PLB) Oral

Placebo: once-daily oral placebo tablets

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Madhukar Trivedi, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2019-07-03
Completion
2019-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078075 on ClinicalTrials.gov